A combined continuing review and modification can be submitted and reviewed at the same time.

Table of Contents Show

Submitting Application Materials
Legacy Submissions and the RAP - Making your Study Complete/Whole
SCR Requirements
"No Continuing Review" Annual Touchpoint

Changes to previously approved research will generally require additional review by RCS or the IRB. If a change requires either a modification (also known as ‘amendment’) to the current study or the submission of a new study, approval for the proposed changes must be secured prior to implementation.

If you must make a change to an approved study to eliminate immediate potential hazards to participants, you may do so without prior approval. If you make changes to eliminate immediate potential hazards, contact RCS as soon as possible for further instructions.

To determine what types of changes require submission prior to initiation, see the Guidance on Amending Previously Approved Research with specific guidance on amendment exempt, expedited, or full board research.

If a modification/amendment submission is necessary, a modification submission is prepared based on review type:

Exempt – For studies previously determined to qualify for exemption, investigators will need to first self-assess to determine if the study appears to continue to qualify for exemption.
- If the study continues to qualify for exemption, a modification/amendment is prepared using the same Exempt Review Application and relevant Category Worksheet(s). Provide responses in the application based on the proposed changes to the research. RCS will review the study to determine that the study continues to qualify for exemption; a determination letter will be issued.
- If the study no longer appears to qualify for exemption, an Initial Review Application and applicable protocol materials will need to be prepared and submitted to RCS for IRB review.
Expedited and Full Review – Studies previously determined to require expedited or full review, must submit a Modification (Amendment) Review Application for any changes to previously approved research. The IRB must determine that all approval criteria specified in the federal regulations continue to be satisfied. If all criteria are satisfied, the IRB will issue an approval for the proposed changes.

The Exempt Review and Amendment Review Applications include a submission checklist on the back page to guide researchers in identifying additional materials required for submission. See below for instructions on how to prepare a submission.

Note: Personnel only modifications (regardless of review type - exempt, expedited, full board) do not need an application.

If you have questions, please contact Research Compliance Services.

Submitting Application Materials

All study materials are submitted to Research Compliance Services (RCS) who will facilitate the review process. All application materials are submitted using the RAP system. The materials and instructions for submitting a modification/amendment depend on the type of study you are modifying:

Legacy studies are those studies established prior to the implementation of the IRB module of the Research Administration Portal (RAP). All legacy studies were migrated to the RAP portal on May 12, 2021. For more information about migrated studies please see our Transitioning Studies page.
RAP studies are those studies established and managed using the IRB module of the Research Administration Portal (RAP).
- If your study was approved through the RAP, you will submit your modification request through the IRB module using RAP versions of the application forms.

Legacy and RAP versions of the application and forms are available on the Applications, Forms, and Guidance page.

To submit a study modification,

click below to access the RAP
select “IRB Module” from the navigation bar
select the “Active” tab
select the study you wish to modify
select “Create Modification/CR”
complete the electronic application pages and upload your materials where prompted.

RAP Portal

Legacy Submissions and the RAP - Making your Study Complete/Whole

Legacy studies are those that were not created in the IRB module of the research administration portal (RAP). If your study identification is all numbers with no letters, it is a legacy study (e.g., 01012015.099). If your study identification starts with "STUDY", it is a RAP study (e.g., STUDY99000999).

Because not all information for legacy studies was able to be migrated to the RAP, the first submission using the RAP for a legacy study will take some extra time and consideration. To make the study complete/whole in the RAP, information must be updated and all currently approved study materials uploaded. The only way to add/change information to the parent study in the RAP make the legacy study complete/whole is through a modification. When submitting a continuing review, you must submit a modification simultaneously if your legacy study has not been completed in the RAP (i.e., if you have not previously updated the legacy study information and uploaded legacy study materials via a RAP modification).

For additional information/guidance on migrated studies and the RAP:

Use the following resources for support:

RAP Investigator Manual for instructions on submitting new studies through the IRB Module of the RAP.
We have created many step-by-step RAP guidance documents to support you! Find these available in the RAP Guidance section of our Guidance Library and in the Help Center within the IRB Module of the RAP.
See additional guidance for Students and Faculty Advisors for additional instructions for submission.
See our training catalog for workshops and other learning opportunities to support you.
Contact Research Compliance Services with any questions.

Per federal regulations outlined in 45 CFR 46.109(e), an approved, federally-sponsored human subjects study must be reviewed, at least annually, by the IRB. For this continuing review, the IRB reviews the:

The IRB may recommend modifications or updates to a study upon continuing review. The continuing review process is not used to update an IRB application at the time of renewal. The study team would submit these changes for IRB review via the amendment process.

Under the revised Common Rule, the following no longer requires continuing review:

Most of the new studies (i.e., those approved after January 21, 2019) that qualify for expedited review
Studies approved prior to January 21, 2019 that have completed subject intervention/interaction, where the activity is limited to either the final analysis of identifiable data/biospecimens or involves accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

The IRB may require continung review for projects, but must document the reason to do so. Common reasons include, but are not limited to:

The project sponsor requires continuing review
The project involves additional regulatory oversight, such as conflict of interest (COI) management.
The research will be conducted internationally or at non-UM sites
An amendment or incident report reveals new findings that require additional oversight
The investigator has had previous serious non-compliance or a pattern of non-serious non-compliance

Continuing review is required for research that is regulated by the Food & Drug Administration (FDA).

SCR Requirements

At U-M the continuing review process is called a Scheduled Continuing Review (SCR). The SCR is an online form completed in U-M's eResearch Regulatory Management (eRRM) system by a member of the study team to:

Report the current status of the research project to the IRB, inclduing the number of subjects enrolled; and
Initiate the IRB review for the renewal of approval prior to the study's expiration date.

Study teams receive an automated email from eRRM at 90, 60, and 30 days prior to a study's expiration date as a reminder to submit an SCR, but it is the Principal Investigator's responsibility to ensure that the SCR is submitted in a timely manner for IRB review.

Lapse in IRB Approval

A human subjects study must retain active IRB approval until the study team has completed the work (e.g., all papers submitted and analyses completed) on the research, or until the data has been completely deidentified, including the destruction of any keys or codes linking the data to subject identifiers. If the study requires continuing review and the approval period expires (i.e., lapses), all research activity must stop until IRB approval is re-established. This means no new subjects may be enrolled in the study, no data may be collected, and data analysis is discontinued. The only exception is when stopping the activity would jeopardize the welfare of the subject. This exception is very rare for the type of research reviewed by the IRB-HSBS.

If the lapse is less than three (3) months, the Prinicpal Investigator (PI) or study team may submit an SCR to initiate an IRB review for approval. If greater than three months, the IRB may require a new application. The IRB has the authority to require a full re-review of the study in cases of lapsed approvals.

Terminating a Study at SCR

Principal Investigators have the option to terminate the study at the time of Scheduled Continuing Review (SCR) if the study is complete (e.g., activity limited to data analysis). The SCR process will direct the PI (or Faculty Advisor for studies where a student serves as the PI) to complete a Termination Report in eRRM to close the project

"No Continuing Review" Annual Touchpoint

For studies that qualify for no continuing review ("No CR"), reporting the project status helps the IRB to monitor the study's progress. To facilitate this, an Annual Touchpoint email is sent to the study team on the anniversary of the qualifying study's approval date.
This system email acts as an annual reminder for study teams to take action, as needed, to update the status of their study through the amendment, incident reporting, or termination processes. The U-M IRB Offices review the Annual Status Report responses and IRB staff may contact investigators if additional information or action by the study team is needed.